Provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of the AstraZeneca products in Gulf. Applies knowledge of current local and global Regulatory trends to identify future regulatory requirements and strategies. Influences Regulatory authorities through regular contacts to improve Regulatory outcomes. Implements strategies to improve quality and efficiency of submissions and licenses maintenance.

Ensures Regulatory compliance aspects throughout product lifecycle to ensure delivery of high quality products to the market, keeping AZRA Systems and portals updated in line with GRP compliance aspect.

Typical Accountabilities

Regulatory Affairs:

• Effective lobbying and influencing on with regulatory agencies and trade associations on products and legislative development issues and monitors changes in the regulatory environment in Gulf to support and advise relevant functions
• Provide strategic regulatory advice support for product developments
• Represent AZRA on relevant external Trade Association committees to ensure AZRA and/or AZ views on key issues are known
• Provide expertise, guidance, and awareness to the product teams, skill groups and global functions in support of dynamic Health Authority Regulatory requirements
• Lead and provide regulatory expertise on global and regional regulatory submissions and health authority briefings
• Ensure adequate risk assessments and mitigation plans are included in the regulatory strategy documents
• Contribute effectively to Global Development programmes, providing expert advice and interpretive inputs on market legislation and requirements that impact on new and existing product registrations
• Ensure all markets remain in compliance with product licences maintained and ensuring improvement plans are in place to close compliance gaps.
• Make a significant contribution to product marketing company strategy
• Works as a partner within relevant product and project teams providing regulatory intelligence and advice, and strategic input, as appropriate.
• Identify global budget priorities, taking careful note of portfolio growth and business needs
• Identify potential complex regulatory risks to global and regional operational plans, and propose options to mitigate risks
• Implement excellent communication within regulatory and other functions in Gulf (eg. ongoing submissions, the short-term plans and long-term plans)
• Communicate all the regulatory updates to the relevant departments to plan for the new products launches accordingly
• Ensure timely & effective New Drug Application NDA submission and line extensions, License Maintenance and Documentation

Leadership and team management:

• Set ambitious goals for the employees of the Regulatory department and ensure their cooperation with other departments of the company to achieve better results
• Identify strengths and development needs, motivate and train subordinates to improve their performance effectiveness and develop functional and leadership competencies.
• Conduct annual goal setting and IDP sessions, feedback and coaching with subordinates according to corporate standards
• Implement control measures to compare the actual results of the work performed with the goals and take appropriate action in case of deviations from the plan.
• Analyze and resolve possible difficulties for the effective work of the team. Create challenges and inspire team to increase productivity.
• Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration

Financial Planning

• Manage Regulatory Affairs budget & reporting team variable costs
• Ensure work & planning of the team is based on clear economic rationale and key activities are carried out within the budget
• Manage resources to optimize investment and maximize returns
• Provide regular forecasts for the budget and projected expenses at the end of the year, re-evaluating the budget in accordance with priorities, markets conditions and a profound understanding of the products on the market.

Stakeholders management

• Build relationships with key internal / external clients, closely cooperating with Gulf business managers and country directors, local country regulators.
• Report on the status of implementation of the tactical plan to internal customers.
• Builds and develops optimum global working relationships and processes with other key stakeholders in AstraZeneca Regulatory Affairs to gain efficiencies
• Ensures effective collaboration across the GCC and Gulf Regulatory Affairs interface enabling rapid and effective submissions, approvals and other product maintenance activities

Corporate responsibility:

• Maintain highest ethical standards and work in a spirit of AstraZeneca Code of Ethics, following rules & norms set by corporate policies
• Ensure that all conducted activities are done in accordance with local legislation and corporate standards.
• Timely report (as per respective procedures): health/environment/wellbeing related accidents; adverse events that you became aware about; change in status of your Conflict of Interest.

Education, Qualifications, Skills and Experience:

Essential:

• Pharmacy/ life sciences degree
• 8-10 yrs of experience in Medical and/or pharmaceutical environment with significant experience of regulatory drug development, manufacture, commercialization or equivalent.
• Proven successful leadership and project management experience
• Knowledge of regulatory procedures and legislation for drug development, product registration, line extension and license maintenance
• 3 years of successful people management
• Scientific & strategic mindset
• Strong influence & negotiation skills
• Regulatory Strategy Development
• Regulatory Submissions & Approval Management
• Regulatory Environment Insight
• Patient Benefit / Risk Assessment

Desirable:

• Broad background of experience of working in several groups in regulatory affairs or experience at a health authority.
• Significant Regulatory Experience across global projects and regions
• Strong commercial awareness
• Problem solving skills
• Develops collaborative working relationships
• Proactively Innovate and Adapt
• Process Management & Continuous Improvement
• Supplier/Partnership Management
• Audits & Inspections Knowledge

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.